Strep A Twist Rapid Test Cassette (K023766), IST-502T Twist Cassettes. Brand Name (Catalog Number): ACON Rapid Device St

FDA device recall Z-1075-2012 · posted 2012-02-22 · Terminated

Recall details

Recalling firm

Alere San Diego

Reason for recall

Alere San Diego is expanding the scope of the voluntary recall of the Strep A Rapid Test Cassette and Twist devices from the single lot that was recalled in January 12, 2011 to all lots of product that were on the market within the expiry period.

Action taken

The firm, Alere, sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 1, 2011 to its customers. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to retain the recall letter for their records as documentation that they have received the recall information. Customers were instructed to follow the directions and return the attached Verification Form. Customers were instructed to use the table in the Verification Form to document all inventory at any of their inventory locations. Customers may use multiple forms to document all sites, products, and lots. Alere will issue credit against PO#ASD811STA for any unused portion of the product based on completion and return of the attached Verification Form. Customers with any technical questions about the information contained in the notification were instructed to contact Alere by phone (877) 866-5309, fax (877) 866-9304 or email: ca2services@Alere.com.

Root cause

Process change control

Status

Terminated

Product code

GTY

Quantity affected

2,797,600 devices (228 lots)

Distribution

Worldwide distribution: USA (nationwide) and countries of : Austria, Canada, Cyprus, Denmark, Finland, Germany, Greece, Hungary, Iceland, Italy, Poland, Portugal, Romania, Slovenia, Spain, Switzerland

Date initiated

2011-09-01

Date posted

2012-02-22

Date terminated

2012-06-28

Location

San Diego, CA

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